SIGNIFOR LAR POWDER FOR SUSPENSION, SUSTAINED-RELEASE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PASIREOTIDE (PASIREOTIDE PAMOATE)

可用日期:

RECORDATI RARE DISEASES CANADA INC

ATC代码:

H01CB05

INN（国际名称）:

PASIREOTIDE

剂量:

30MG

药物剂型:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

组成:

PASIREOTIDE (PASIREOTIDE PAMOATE) 30MG

给药途径:

INTRAMUSCULAR

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

Somatostatin Agonists

產品總結:

Active ingredient group (AIG) number: 0154790008; AHFS:

授权状态:

APPROVED

授权日期:

2020-05-21

产品特点

_ _
_Page 1 of 66_
PRODUCT MONOGRAPH
PR
SIGNIFOR
® LAR
®
Pasireotide for Injectable Suspension
10 mg, 20 mg, 30 mg, 40 mg, and 60 mg pasireotide (as pasireotide
pamoate) per vial
SOMATOSTATIN AND ANALOGUES
Recordati Rare Diseases Canada Inc.
Toronto, Ontario, Canada M4N 3N1
Date of Initial Approval:
February 10, 2015
Date of Revision:
May 19, 2020
Submission Control No: 237292
SIGNIFOR and LAR are registered trademarks.
_ _
_ _
_Page 2 of 66_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION ...................... ERROR! BOOKMARK NOT
DEFINED.
INDICATIONS AND CLINICAL USE ............................ ERROR!
BOOKMARK NOT DEFINED.
CONTRAINDICATIONS .................................................
ERROR! BOOKMARK NOT DEFINED.
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................30
OVERDOSAGE
................................................................................................................38
ACTION AND CLINICAL PHARMACOLOGY
............................................................38
STORAGE AND STABILITY
..........................................................................................45
SPECIAL HANDLING INSTRUCTIONS
.......................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................46
PART II: SCIENTIFIC INFORMATION
...............................................................................47
PHARMACEUTICAL INFORMATION
..........................................................................47
CLINICAL TRIALS
.